ViiV Healthcare announces regulatory submissions for dolutegravir in the EU, US and Canada

ViiV Healthcare today announced the submission of regulatory applications in the European Union (EU), United States (US) and Canada for the investigational integrase inhibitor dolutegravir (S/GSK1349572) for the treatment of HIV infection in adults and adolescents, specifically:

• A Marketing Authorisation Application to the European Medicines Agency for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
• A New Drug Application to the US Food and Drug Administration for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.
• A New Drug Submission to Health Canada for dolutegravir for the treatment of HIV infection in adults and children aged 12 years and older.

“These regulatory submissions are an important step for ViiV Healthcare, representing our commitment as a company to bring new treatments to people living with HIV.” said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare. “We are encouraged by the comprehensive data package supporting dolutegravir, and believe that it has the potential to offer an important new option for the treatment of both naïve and treatment-experienced patients with HIV.”